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. 2021 Oct 1;5(19):3748–3759. doi: 10.1182/bloodadvances.2020004146

Table 2.

Venetoclax and carfilzomib PK parameters in the plasma

Cohort 1 Cohort 2 Cohort 3 Cohort 4
Venetoclax 400 mg+ Venetoclax 800 mg+ Venetoclax 800 mg+ Venetoclax 800 mg+
carfilzomib 27 mg/m2+ carfilzomib 27 mg/m2+ carfilzomib 70 mg/m2+ carfilzomib 56 mg/m2+
dexamethasone 40 mg dexamethasone 40 mg dexamethasone 40 mg dexamethasone 40 mg
C1D1, n = 4 C1D15, n = 4 C1D1, n = 2* C1D15, n = 3 C1D1, n = 6 C1D15, n = 6 C1D1, n = 3 C1D15, n = 3
Venetoclax PK parameters
 Tmax, h 6.0 (4.0, 8.0) 4.0 (4.0, 6.0) 6.0, 24.0 6.0 (6.0, 8.0) 6.0 (6.0, 6.0) 6.0 (6.0, 8.0) 6.0 (4.0, 6.0) 6.0 (4.0, 6.0)
 Cmax, µg/mL 1.57 (1.58, 9) 2.18 (2.47, 57) 0.505, 1.23 2.05 (2.59, 86) 0.915 (1.13, 68) 2.29 (2.69, 51) 1.42 (1.85, 88) 2.85 (2.94, 28)
 AUC24, µg × h per mL 19.9 (19.9, 9) 30.2 (33.1, 54) 9.34, 16.7 31.7 (39.9, 86) 14.2 (15.2, 44) 33.0 (39.3, 49) 20.8 (24.9, 77) 50.9 (52.5, 30)
Carfilzomib PK parameters n = 4 n = 3 n = 3 n = 3 n = 5 n = 6 n = 3 n = 3
 Tmax, h 0.58 (0.57, 0.70) 0.57 (0.55, 0.62) 0.58 (0.52, 0.58) 0.67 (0.58, 0.70) 0.55 (0.52, 0.75) 0.55 (0.27, 0.92) 0.52 (0.50, 0.53) 0.50 (0.50, 0.53)
 Cmax, ng/mL 135 (384, 87) 501 (574, 67) 351 (368, 34) 455 (483, 42) 519 (661, 62) 852 (982, 50) 263 (377, 95) 429 (600, 97)
 AUCinf, ng × h per mL 72.1 (166, 85) 212 (241, 65) 146 (155, 37) 209 (224, 47) 241 (294, 61) 381 (401, 29) 121 (160, 84) 247 (314, 89)
 t1/2, h§ 0.67 (0.3) 0.75 (0.4) 0.55 (0.1) 0.63 (0.1) 0.58 (0.2) 0.98 (0.3) 0.70 (0.6) 0.83 (0.5)

Data are reported as geometric mean (arithmetic mean, %CV) unless otherwise specified.

AUC24, area under the plasma concentration-time curve over a 24-hour dose interval; AUCinf, AUC from time 0 to infinity; C1D1: cycle 1, day 1; C1D15: cycle 1, day 15; Cmax, maximum observed plasma concentration; CV, coefficient of variation; t1/2, terminal elimination half-life; Tmax, time to Cmax.

*

n = 2; presented as individual values.

Median (minimum, maximum).

n = 4.

§

Harmonic mean (pseudo standard deviation).